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ID

34693

Beschrijving

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Trefwoorden

Versies (1)
  1. 23-01-19 23-01-19 -
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GlaxoSmithKline

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23 januari 2019

DOI

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Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Engels

    Unscheduled 12-Lead ECG Form

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Screening number
    Beschrijving

    Subject Screening No.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Beschrijving

    Subject Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Unscheduled 12-Lead Electrocardiogram
    Beschrijving

    Unscheduled 12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI-2
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Actual Time
    Beschrijving

    Actual Time

    Datatype

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Reason for Unscheduled Assessment
    Beschrijving

    Reason for Unscheduled Assessment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,2]
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Comment
    Beschrijving

    Comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Comment Key
    Beschrijving

    Comment Key

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C1706198 (Key - value)
    Clinical Staff Initials
    Beschrijving

    Clinical Staff Initials

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C1552089 (Staff Member)
    Terug naar het begin van de pagina

    Similar models

    Unscheduled 12-Lead ECG Form

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Unscheduled 12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Reason for Unscheduled Assessment
    Item
    Reason for Unscheduled Assessment
    text
    C0220825 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Comment Key
    integer
    C0947611 (UMLS CUI [1,1])
    C1706198 (UMLS CUI [1,2])
    Comment Key
    Code List
    Comment Key
    CL Item
    Not done due to adverse event (describe) (1)
    CL Item
    Late due to late running of previous assessment (2)
    CL Item
    Subject not in attendance (confirm time delay) (3)
    CL Item
    Late due to technical problems (confirm time delay) (4)
    CL Item
    Other (describe) (5)
    Clinical Staff Initials
    Item
    Clinical Staff Initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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